The stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates
Upon approval of a drug, the stability of the API and the FPP has to be studied intensively because it determines the shelf-life. If a drug is found to be stable, the expiry date is arbitrary set to five years at the maximum, if a drug tends to undergo degradation, the expiry date is set shorter. Th...
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| Format: | Doctoral Thesis |
| Language: | English |
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2019
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| Online Access: | https://opus.bibliothek.uni-wuerzburg.de/frontdoor/index/index/docId/18069 http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-180695 https://nbn-resolving.org/urn:nbn:de:bvb:20-opus-180695 https://opus.bibliothek.uni-wuerzburg.de/files/18069/Zilker_Markus_The_stability.pdf |